Publication Date

4-30-2015

Keywords

pragmatic trials, stakeholder engagement

Abstract

Background/Aims: Successful pragmatic trials require close partnership between researchers and health care organizations. We describe the process by which we engaged clinical and operational leaders from three Kaiser Permanente (KP) regions to design a trial to test alternative population-based models for diabetes prevention.

Methods: The study leveraged ongoing efforts in each region to develop a populationwide approach to diabetes prevention. Working with clinical leaders from KP Northwest (KPNW), we designed an initial study that we then took to the leadership of KP Southeast and KP Hawaii. We also obtained the endorsement of KP’s national Care Management Institute (CMI). After submitting a successful letter-of-intent to the Patient-Centered Outcomes Research Institute, we worked with our health plan partners to develop a full proposal that is presently under review.

Results: Throughout the proposal development process, we consulted key regional and national health plan stakeholders on various design issues. We also included the KPNW lead for diabetes management as a full co-investigator and regular member of our weekly planning meetings. As a direct result of these interactions, we dropped our initial three-arm design in favor of a two-arm design because it became clear that our planned low-intensity arm would likely be obsolete by the time the grant was funded. We also decided to focus our study on those at highest risk for progressing to diabetes since this was where the organization clearly intended to focus its greatest energy. Finally we leveraged an ongoing demonstration project being coordinated by the CMI to evaluate an online diabetes prevention curriculum that was seen as a scalable model for providing a proven lifestyle change program to our members nationwide. We incorporated this program into our intervention design and conducted interviews with patients to better understand their perspective regarding the overall usefulness of the program and barriers to participation. To meet the needs of members who preferred face-face classes, we also partnered with local diabetes programs in our communities to provide this option.

Discussion: Our process of stakeholder engagement directly informed the design of the trial and helped to ensure strong institutional support for the study should it be funded.